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临床试验/CTRI/2026/01/100279
CTRI/2026/01/100279尚未招募不适用

Elevated Placental Growth Factor at 11 to 13 weeks 6 days period of gestation as a predictor of Gestational diabetes mellitus

Gauri Mann1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
试验地点
1
主要终点
To determine if elevated PlGF can predict GDM later on in pregnancy

研究概览

简要总结

This study , titles “Elevated placental growth factor at 11-13 weeks

6 days period of gestation as a predictor of gestational diabetes

mellitus,” is a prospective observational cohort study conducted at a

tertiary care hospital, utilizing data collected over the Antenatal

period , starting from time of NT Scan till termination of pregnancy ,

of patients that fulfil the inclusion criteria . Data collected over the

antenatal period will include PlGF levels at the time of NT Scan and

aneuplaoidy screening ( part of regular ANC , done after 11

completed weeks but before 14 completed weeks , that is by 13

weeks 6 days of gestation) , OGTT/GCT levels ( part of ANC , done

between 24-28 weeks in regular clinical practice) , maternal details

such as GPLA score, anthropometric measurements ( 1 st trimester

BMI, height) collected in 1 st trimester at the time of NT scan /

Aneuploidy screening . Patients will be followed up after NT

scan/aneuploidy screening during regular ANC visits . OGTT values (

done as part of regular ANC visit between the POG 24-28 weeks) will

be recorded in a proforma and patient will be classified as GDM

(gestational diabetes mellitus) and non GDM based on the same

according to standard cut-offs used in regular practice. Subsequent

FBS/PPBS values ( part of routine ANC tests for GDM patients) will

be recorded in the same proforma. Data will be entered in machine

learning tool (Random forest ) to help in formulation of a model that

will help predict GDM development . Ethical approval will be

obtained , with all data anonymized to maintain confidentiality. The

study’s findings can help in providing a valuable early predictor of

GDM in pregnancy that could potentially decrease both maternal and

fetal morbidity and mortality risks.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 48.00 Year(s)(—)
性别
Female

入选标准

  • •Singleton pregnancies at 11-13 weeks 6 days of gestation at the time of combined screening by USG and biochemistry markers in the maternal serum and who continue antenatal check ups in our hospital.
  • •Willing to participated in the study and give informed consent.

排除标准

  • •Multiple pregnancies
  • •Pregnancies with pre-existing hypertensive disorders or Pre- existing Diabetes Mellitus ( type 1 and 2 ), previous pregnancies with GDM
  • •Pregnancies with known chromosomal abnormalities and/or structural defects
  • •Pregnancies that resulted in IUD or abortions
  • •Pregnancies with early onset FGR.

结局指标

主要结局

To determine if elevated PlGF can predict GDM later on in pregnancy

时间窗: At the end of pregnancy

次要结局

未报告次要终点

研究者

发起方
Gauri Mann
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Gauri Mann

Kasturba Hospital , Manipal

研究点 (1)

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